Sensor model supervisor for a closed-loop insulin infusion system

a closed-loop insulin infusion and sensor model technology, applied in the field of drug delivery systems, can solve the problems of less desirable use of traditional external infusion pumps and current pumps limited by the speed

Active Publication Date: 2016-09-08
MEDTRONIC MIMIMED INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although offering control, pump therapy can suffer from several complications that make use of traditional external infusion pumps less desirable for the user.
However, current pumps are still limited by the speed of the insulin they are using.

Method used

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  • Sensor model supervisor for a closed-loop insulin infusion system
  • Sensor model supervisor for a closed-loop insulin infusion system
  • Sensor model supervisor for a closed-loop insulin infusion system

Examples

Experimental program
Comparison scheme
Effect test

case a

[0435

If (tP is not in the time window (tR−tDiffmin : tR)), the following logicis checked.If (CFmin ≦ CFR ≦ CFmax)   If (t−tRecent ≦ tR ≦ t)      If (tR−tDiffmax ≦ tP ≦ tR−tDiffmin)         If (CFmax ≦ CFP ≦ CFmax)            Calculate CFchange with CFR as the            CFcurrent and with CFP as the CFprevious            in Equation 50 stated above            If (CFchange ≦ CFchangeTh)               Enter Closed Loop            Else Cannot enter closed loop at that time         Else Cannot enter closed loop at that time      Else Cannot enter closed loop at that time   Else Cannot enter closed loop at that timeElse Cannot Enter Closed Loop

[0436]If any of the above conditions is not met, the system remains in the open-loop mode. Thus, in order to enter the closed-loop mode, new calibration(s) that satisfy all of the conditions in Case A (or Case B as described below) will be required.

case b

[0437

If (tP is in the time window (tR−tDiffmin : tR)),CFV = most recent CF value in the time window oftR−tDiffmax : tR−tDiffmintV = time when CFV was obtainedIf (CFmin ≦ CFR ≦ CFmax)   If there is a CFV available         Calculate CFchange with CFR as the CFcurrent         and with CFV as the CFprevious in Equation         50 stated above         If (CFV, CFR and all CF values between times tV         and tR lie in the range of (CFmin:CFmax) AND         CFchange between CFV and CFR         is ≦ CFchangeTh)            Enter closed loop         Else Cannot enter closed loop at that time      Else Cannot enter closed loop at that time   Else Cannot enter closed loop at that timeElse Cannot Enter Closed Loop

[0438]If any of the above conditions is not met, the system remains in the open-loop mode. Thus, in order to enter the closed-loop mode, new calibration(s) that satisfy all of the conditions in Case A or Case B will be required.

[0439]In accordance with certain variations of the close...

case c

[0449

[0450]Case C corresponds to a scenario where the time of prior calibration is greater than 120 minutes before the most recent calibration. In addition, the recent calibration factor (CFR) and the prior calibration factor (CFP) are within limits as shown in the following logical expressions.

CFmin≦CFR≦CFmax  (eq A2)

CFmin≦CFP≦CFmax  (eq A3)

Here, CFR is the recent calibration factor value, CFP is the prior calibration value, CFmin is the minimum value for the calibration factor that is set as 2.5 mg / dL per nA, and CFmax is the maximum value for the calibration factor that is set as 6 mg / dL per nA.

[0451]For Case C, the time of recent calibration (tR) is within two hours of the start of closed-loop initiation as shown in the following logical expression.

t−tRecent≦tR≦t  (eq A4)

Here, tR is the time of recent calibration, t is the time when attempting to enter the closed-loop mode, and tRecent is the time window for the most recent calibration before attempting to start the closed-loop ...

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Abstract

An insulin infusion device includes a processor architecture, and a memory element that stores executable instructions to perform a method of controlling delivery of insulin to a user. The method operates the device in a closed-loop mode to deliver insulin, obtains patient-specific parameters for a current time sample, and estimates a plasma insulin value and a blood glucose value for the user based on at least some of the patient-specific parameters. The estimating is also based on a previously estimated plasma insulin value obtained for a previous time sample, and a previously estimated blood glucose value obtained for the previous time sample. A predicted sensor glucose value is generated for the current time sample, and the closed-loop mode or a safe basal mode is selected for controlling operation of the insulin infusion device in accordance with the selected mode.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. patent application Ser. No. 13 / 870,907, filed Apr. 25, 2013, which claims the benefit of: U.S. provisional patent application No. 61 / 694,950, filed Aug. 30, 2012 and titled “Closed Loop System” (now expired); U.S. provisional patent application No. 61 / 694,961, filed Aug. 30, 2012 and titled “Closed Loop Mobile System” (now expired); and U.S. provisional patent application No. 61 / 812,874, filed Apr. 17, 2013 and titled “Closed Loop System” (now expired).TECHNICAL FIELD[0002]Embodiments of the subject matter described herein relate generally to drug delivery systems and more specifically to systems for controlling the infusion rate of insulin based on state variable feedback.BACKGROUND[0003]The pancreas of a normal healthy person produces and releases insulin into the blood stream in response to elevated blood plasma glucose levels. Beta cells (β-cells), which reside in the pancreas, produc...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61M5/172G06F19/00A61B5/145A61M5/142A61B5/00G16Z99/00
CPCA61M5/1723A61M5/14244A61B5/4839A61M2230/005G06F19/3468A61M2230/201A61M2205/52A61B5/14532A61B5/746A61B5/14503G16H20/17G16Z99/00A61M2005/14208
Inventor GROSMAN, BENYAMINWU, DIROY, ANIRBANPARIKH, NEHA J.
Owner MEDTRONIC MIMIMED INC
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